FDA Approves Nubeqa Tablets for Men with Non-metastatic Castration-resistant Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved Nubeqa (darolutamide) tablets to treat men with non-metastatic castration-resistant prostate cancer (nmCRPC).

“We know that men with nmCRPC are still in the prime of their lives and are at a critical point in their disease when action needs to be taken,” Howard R. Soule, PhD, executive vice president and chief science officer of the Prostate Cancer Foundation (PCF), said in a press release.

“For 26 years, PCF has been focused on research aimed at improving patient outcomes and we welcome the addition of new treatment options that provide men with more choices when working with their doctor to select what’s right for them,” Soule added.

Nubeqa, formerly known as BAY-1841788, is a prostate cancer medication jointly developed by Bayer and Orion. It is an inhibitor of androgen receptors, which are proteins found on the surface of cells that bind to male hormones, interrupting the androgen signaling cascade and preventing cancer cells from receiving growth signals.

The treatment has been approved under Priority Review, a designation exclusively for medications meant to treat serious medical conditions that demonstrate clinical superiority in their safety or efficacy over others currently available.

The FDA’s decision was based on findings from the multi-center, randomized, double-blind, placebo-controlled ARAMIS Phase 3 trial (NCT02200614) that has been designed to evaluate the safety and efficacy of Nubeqa among patients with nmCRPC.

The study enrolled a total of 1,509 patients who were randomly assigned to receive either Nubeqa (600 mg, twice a day) or a placebo, in combination with androgen deprivation therapy.

The trial’s primary endpoint was to assess patients’ metastasis-free survival (MFS), which is the period of time from patients’ allocation to treatment until the first sign of cancer spreading or death by any cause, whichever occurred first.

Secondary endpoints included patients’ overall survival and time to pain progression, which was defined as the period of time from the beginning of the study until the patients had at least a two-point worsening on the Brief Pain Inventory-Short Form score from baseline, or until they had to initiate treatment with opioids to control their pain.

According to ARAMIS topline data, Nubeqa prolonged the time that patients lived without cancer spreading to other tissues and organs from 18.4 months to 40.4 months, which corresponds to a 59% reduction in the risk of cancer spread or death.

Although data about patients’ overall survival were still unavailable at the time of the analysis, the MFS findings were supported by a significant delay in time to pain progression among patients treated with Nubeqa (40.3 months) compared with those treated with a placebo (25.4 months).

The percentage of patients who had to discontinue treatment due to adverse events was identical in both groups (9%). The most frequent causes of treatment discontinuation in patients treated with Nubeqa included heart failure (0.4%) and death (0.4%).

Adverse events occurring more frequently among patients treated with Nubeqa, compared with those treated with a placebo, included fatigue (16% versus 11%), pain in the extremities (6% versus 3%) and skin rashes (3% versus 1%).

“With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC,” said Robert LaCaze, executive committee member of Bayer’s pharmaceuticals division and head of its oncology strategic business unit.

“Bayer is proud to take this latest step forward in the nmCRPC treatment landscape. Nubeqa is the newest addition to our prostate cancer portfolio and reflects Bayer’s commitment to finding treatments for men at different stages along the prostate cancer continuum,” he added.

In the meantime, Bayer has also submitted applications seeking the approval of Nubeqa in Europe, Japan, and other countries.